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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02535104 |
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Date of registration:
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22/08/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Safety and Efficacy Study of Topical Ranpirnase to Treat Genital Warts (HPV)
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Scientific title:
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Phase II Clinical Study, Double Blinded, Multicentric, Controlled Against Placebo, in Parallel Groups, to Evaluate the Efficacy and Safety of a Topical Product Containing Ranpirnase in Genital Warts - HPV |
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Date of first enrolment:
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February 2016 |
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Target sample size:
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70 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02535104 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Bolivia
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Contacts
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Name:
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Edgar Valdez, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Director - Research site |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of external genital / perianal warts with at least 2 warts and no more than
30 lesions
- Accept to follow study instructions / signature of IC
- Abstain from sexual intercourse for 6 hours after applying the study product during
the time of the study.
Exclusion Criteria:
- Any topical and/or destructive treatments for external genital warts within 4 weeks
(within 12 months for imiquimod and within 12 weeks for sinecatechins) prior to
enrollment (i.e., the randomization visit)
- Non pregnant. For women in reproductive age it would be required pregnancy test, and
the use of double barrier contraceptives.
- Any of the following conditions:
- Known allergy to the study product
- Internal (rectal, urethral) warts that required or were undergoing treatment;
- A dermatological disease (e.g., psoriasis) or skin condition in the area, which may
interfere with the evaluation.
- Imiquimod 5% cream (Aldara®)
- Any marketed or investigational HPV vaccines
- Sinecatechins (Veregen)
- Interferon or interferon inducers
- Cytotoxic drugs
- Immunomodulators or immunosuppressives
- Oral or parenteral corticosteroids (inhaled/intranasal steroids are permitted)
- Oral antiviral drugs (with the exception of HAART, oral acyclovir and acyclovir
related drugs) for suppressive or acute therapy herpes; or oseltamivir for prophylaxis
or for influenza)
- Topical antiviral drugs (including topical acyclovir and acyclovir related drugs) in
the areas under treatment
- Podophyllotoxin/Podofilox in the treatment areas
- Any topical prescription medications in the treatment areas
- Dermatologic procedures or surgery in the treatment areas
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Papillomavirus Infections
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Condylomata Acuminata
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Sexually Transmitted Diseases
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Intervention(s)
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Drug: Vehicle
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Drug: Ranpirnase
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Primary Outcome(s)
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Size of lesions
[Time Frame: Up to 60 days]
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Secondary Outcome(s)
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Number of lesions
[Time Frame: Up to 60 days]
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Secondary ID(s)
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TAMIR1501HPV
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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